ImportRefusal LogoImportRefusal

KUANGYE (DONGGUAN) TECHNOLOGY CO., LTD.

⚠️ Moderate Risk

FEI: 3016617404 • Dongguan, Guangdong • CHINA

FEI

FEI Number

3016617404

📍

Location

Dongguan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

No. 35 Lihui Road, Qingxi Town, Dongguan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

36.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
7/1/2020
Latest Refusal
6/4/2020
Earliest Refusal

Score Breakdown

Violation Severity
67.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

4793×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
7/1/2020
80NZJRESPIRATOR, N95, HOME USE
479DV QUALITY
Division of Southeast Imports (DSEI)
6/21/2020
80NZJRESPIRATOR, N95, HOME USE
479DV QUALITY
Division of West Coast Imports (DWCI)
6/4/2020
80NZJRESPIRATOR, N95, HOME USE
223FALSE
479DV QUALITY
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is KUANGYE (DONGGUAN) TECHNOLOGY CO., LTD.'s FDA import refusal history?

KUANGYE (DONGGUAN) TECHNOLOGY CO., LTD. (FEI: 3016617404) has 3 FDA import refusal record(s) in our database, spanning from 6/4/2020 to 7/1/2020.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. KUANGYE (DONGGUAN) TECHNOLOGY CO., LTD.'s FEI number is 3016617404.

What types of violations has KUANGYE (DONGGUAN) TECHNOLOGY CO., LTD. received?

KUANGYE (DONGGUAN) TECHNOLOGY CO., LTD. has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about KUANGYE (DONGGUAN) TECHNOLOGY CO., LTD. come from?

All FDA import refusal data for KUANGYE (DONGGUAN) TECHNOLOGY CO., LTD. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.